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THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutritionnote, and in particular Article 9(2) thereof,Whereas:
(1)Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation.
(2)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3)The application concerns the authorisation of the preparation of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649 as a feed additive for chickens for fattening, other poultry for fattening and ornamental birds, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘gut flora stabilisers’.
(4)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 May 2025note that, under the proposed conditions of use, the preparation of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649 is safe for the target species, consumers and the environment. The Authority also concluded that the preparation of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649, in concentrated form is not irritant to the skin or eyes. Considering the similarity in composition, this conclusion can be extended to diluted form provided it is formulated with only calcium carbonate. Both forms of the additive are considered skin and respiratory sensitisers, and any exposure via skin or respiratory tract is considered a risk. The Authority further concluded that the preparation of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649 has the potential to be efficacious in chickens for fattening, other poultry for fattening and ornamental birds at a proposed minimum inclusion level of 3 × 107 total CFU/kg of complete feedingstuffs. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5)In view of the above, the Commission considers that the preparation of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649 satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for poultry for fattening and ornamental birds. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.
(6)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1Authorisation#
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2Entry into force#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
| Identification number of the feed additive | Name of the holder of authorisation | Name of the additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|---|
| CFU/kg of complete feed with a moisture content of 12 % | |||||||||
| Category: zootechnical additives. Functional group: gut flora stabilisers. | |||||||||
| 4b1898 | S.I.Lesaffre | Preparation of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649 | Additive compositionPreparation of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 andBacillus licheniformis NRRL B-67649 containing a minimum total of Bacillus spp. (ratio 1:1:1):2 × 108 CFU/g additive.Solid formsCharacterisation of the active substanceViable cells of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 andBacillus licheniformis NRRL B-67649.Analytical methodnoteIdentification: DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) (CEN/TS 17697)Enumeration in the feed additive, premixtures, compound feed: Spread-plate method on tryptone soya agar (EN 15784) | Poultry for fatteningOrnamental birds | - | 3 × 107 | - | 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.2. The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: diclazuril, narasin, maduramicin ammonium, salinomycin sodium, monensin sodium, robenidine hydrochloride, the combination narasin with nicarbazin, lasalocid or halofuginone.3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, and skin protective equipment. | 1 January 2036 |
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